Effect of Huaier Granule on Nephrotoxicity Associated With Targeted Therapy for Advanced Hepatocellular Carcinoma.

• Status: Not yet recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, single-arm, single-center, exploratory study. The purpose of this study is to explore the effect of Huaier Granule on nephrotoxicity associated with anti-angiogenesis targeted therapy for advanced hepatocellular carcinoma.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Collaborator: LinkDoc Technology (Beijing) Co. Ltd.

Criteria

Inclusion Criteria:

1. 18 years and older

2. Meeting the clinical diagnostic criteria of primary liver cancer, diagnosed as advanced hepatocellular carcinoma.

3. Receiving VEGFR-TKIs for advanced hepatocellular carcinoma.

4. Urinalysis indicates urine protein positive.

5. Urine protein level greater than 0.3 grams and less than 3.5 grams per 24 hours.

6. No Huaier granule were used within 1 month before enrollment.

7. Agree to use Huaier granule after enrollment.

8. Expected survival time not less than 6 months.

9. Volunteer to join the study and sign the informed consent form.

Exclusion Criteria:

1. Allergic to the components of Huaier granule, or avoid to use Huaier granule or use with caution.

2. Not able to take medication orally.

3. Must use or are using drugs that may affect proteinuria other than VEGFR-TKIs, including but not limited to bevacizumab, ACEI, glucocorticoids (more than 3 weeks), traditional Chinese medicine (refer to drug instructions).

4. Concomitant with other diseases that can lead to proteinuria, including but not limited to nephropathy, hypertension, urinary infections, systemic lupus erythematosus, multiple myeloma.

5. Pregnant or lactating women or women prepare for pregnancy.

6. Participating in clinical trials of other drugs that intend to treat proteinuria.

7. Refused to cooperate with follow-up.

8. Other reasons that the researcher considers unsuitable to participate in this study.